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Last Updated: March 29, 2024

CLINICAL TRIALS PROFILE FOR GALLIUM CITRATE GA 67


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All Clinical Trials for Gallium Citrate Ga 67

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00477503 ↗ Nuclear Imaging of Human CSF Flow Using Ga-67 Citrate and In-111 DTPA Terminated M.D. Anderson Cancer Center Phase 1 2007-05-01 - Primary Objective will be to evaluate the use of Ga-67 citrate as an alternative radiopharmaceutical for CSF imaging. - Secondary Objective will be to evaluate the biodistribution, pharmacokinetics and radiation dosimetry of In 111 DTPA and gallium-67 after intrathecal injection during remission of leptomeningeal metastasis (LM) and during LM occurrence, remission and recurrence.
NCT02391025 ↗ Gallium-68 Citrate PET Used in Prostate Cancer Recruiting United States Department of Defense Early Phase 1 2015-05-28 This is a single center cross-sectional imaging study investigating the use of gallium-68 citrate PET in patients with metastatic castration-resistant prostate cancer who are planning to undergo a metastatic tumor biopsy on protocol NCT02432001 (CC#125519). The study population will consist of patients with metastatic castration-resistant prostate cancer who are undergoing a metastatic tumor biopsy as part of clinical protocol NCT02432001 (CC#125519), with evidence of resistance to androgen signaling inhibition. The study will involve gallium-68 PET scan obtained at single time point, followed by radiographically-guided metastatic tumor biopsy within 14 days of PET scan.
NCT02391025 ↗ Gallium-68 Citrate PET Used in Prostate Cancer Recruiting Rahul Aggarwal Early Phase 1 2015-05-28 This is a single center cross-sectional imaging study investigating the use of gallium-68 citrate PET in patients with metastatic castration-resistant prostate cancer who are planning to undergo a metastatic tumor biopsy on protocol NCT02432001 (CC#125519). The study population will consist of patients with metastatic castration-resistant prostate cancer who are undergoing a metastatic tumor biopsy as part of clinical protocol NCT02432001 (CC#125519), with evidence of resistance to androgen signaling inhibition. The study will involve gallium-68 PET scan obtained at single time point, followed by radiographically-guided metastatic tumor biopsy within 14 days of PET scan.
NCT02494921 ↗ LEE011 (Ribociclib) in Combination With Docetaxel Plus Prednisone in mCRPC Completed Novartis Phase 1/Phase 2 2015-11-20 This is a Phase Ib/II open label clinical trial in patients with metastatic castration resistant prostate cancer. The objective of the phase Ib portion of the study is to establish the maximum tolerated dose (MTD) and dose limiting toxicities (DLT) of docetaxel (75 mg/m2 IV q21 days) and prednisone (5mg orally BID) in combination with ribociclib in escalating oral daily doses in patients with metastatic castrate resistant prostate cancer (mCRPC) with prior resistance to abiraterone and/or enzalutamide who have not undergone prior chemotherapy for metastatic disease. Up to three cohorts will be enrolled to determine the MTD and DLT profile of this combination during Phase 1b. Dose escalation will follow the standard 3+3 design. The dosing schedule is being chosen to allow patients to be exposed to the most efficacious dosing schedule of docetaxel (75 mg/m2 every 3 weeks). If there is excess toxicity observed with the treatment combination at the first dose level (dose level I), an alternative dosing schema may be pursued with weekly docetaxel treatment (35 mg/m2 weekly), which has demonstrated activity in mCRPC and decreased risk of cytopenias compared with every 3 week dosing schedule. The Phase II portion (N = 29) of the study is a single arm, two stage, open-label study of ribociclib (dosed at the RP2D) in combination with docetaxel and prednisone to determine the efficacy and further define the safety of the treatment combination. Patients will be treated with the combination of ribociclib plus docetaxel + prednisone for up to 9 cycles. If there is no evidence of radiographic or clinical disease progression after 9 cycles of protocol therapy, patients may continue on single agent maintenance ribociclib until the time of disease progression. Patients will have the option of starting maintenance ribociclib after 6 cycles of docetaxel if stable disease or better on re-staging scans. The dose of ribociclib used during maintenance will be the same dose as that immediately preceding cessation of docetaxel treatment.
NCT02494921 ↗ LEE011 (Ribociclib) in Combination With Docetaxel Plus Prednisone in mCRPC Completed Rahul Aggarwal Phase 1/Phase 2 2015-11-20 This is a Phase Ib/II open label clinical trial in patients with metastatic castration resistant prostate cancer. The objective of the phase Ib portion of the study is to establish the maximum tolerated dose (MTD) and dose limiting toxicities (DLT) of docetaxel (75 mg/m2 IV q21 days) and prednisone (5mg orally BID) in combination with ribociclib in escalating oral daily doses in patients with metastatic castrate resistant prostate cancer (mCRPC) with prior resistance to abiraterone and/or enzalutamide who have not undergone prior chemotherapy for metastatic disease. Up to three cohorts will be enrolled to determine the MTD and DLT profile of this combination during Phase 1b. Dose escalation will follow the standard 3+3 design. The dosing schedule is being chosen to allow patients to be exposed to the most efficacious dosing schedule of docetaxel (75 mg/m2 every 3 weeks). If there is excess toxicity observed with the treatment combination at the first dose level (dose level I), an alternative dosing schema may be pursued with weekly docetaxel treatment (35 mg/m2 weekly), which has demonstrated activity in mCRPC and decreased risk of cytopenias compared with every 3 week dosing schedule. The Phase II portion (N = 29) of the study is a single arm, two stage, open-label study of ribociclib (dosed at the RP2D) in combination with docetaxel and prednisone to determine the efficacy and further define the safety of the treatment combination. Patients will be treated with the combination of ribociclib plus docetaxel + prednisone for up to 9 cycles. If there is no evidence of radiographic or clinical disease progression after 9 cycles of protocol therapy, patients may continue on single agent maintenance ribociclib until the time of disease progression. Patients will have the option of starting maintenance ribociclib after 6 cycles of docetaxel if stable disease or better on re-staging scans. The dose of ribociclib used during maintenance will be the same dose as that immediately preceding cessation of docetaxel treatment.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Gallium Citrate Ga 67

Condition Name

Condition Name for Gallium Citrate Ga 67
Intervention Trials
Lymphoma, Large B-Cell, Diffuse 1
Metastatic Prostate Adenocarcinoma 1
Metastatic Prostate Small Cell Carcinoma 1
Brain Tumors 1
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Condition MeSH

Condition MeSH for Gallium Citrate Ga 67
Intervention Trials
Prostatic Neoplasms 3
Carcinoma 2
Infections 1
Endocarditis 1
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Clinical Trial Locations for Gallium Citrate Ga 67

Trials by Country

Trials by Country for Gallium Citrate Ga 67
Location Trials
United States 15
France 1
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Trials by US State

Trials by US State for Gallium Citrate Ga 67
Location Trials
California 3
New Jersey 2
Oklahoma 1
Nebraska 1
Maine 1
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Clinical Trial Progress for Gallium Citrate Ga 67

Clinical Trial Phase

Clinical Trial Phase for Gallium Citrate Ga 67
Clinical Trial Phase Trials
Phase 2 5
Phase 1/Phase 2 2
Phase 1 1
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Clinical Trial Status

Clinical Trial Status for Gallium Citrate Ga 67
Clinical Trial Phase Trials
Recruiting 3
Terminated 2
Completed 1
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Clinical Trial Sponsors for Gallium Citrate Ga 67

Sponsor Name

Sponsor Name for Gallium Citrate Ga 67
Sponsor Trials
Rahul Aggarwal 3
Rutgers, The State University of New Jersey 2
Novartis 1
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Sponsor Type

Sponsor Type for Gallium Citrate Ga 67
Sponsor Trials
Other 9
Industry 4
U.S. Fed 2
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